A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.
This study is multiple-center, open-label, Phase II clinical trial and uses Simon's Two-Stage Optimal design. Subjects with chronic hepatitis B (CHB) will be enrolled sequentially and receive up to 3 doses of HLX10 at 1 mg/kg for four weeks apart. First six subjects will be enrolled in the safety run-in period. If there are no serious adverse events noticed in these 6 subjects up to 6 weeks after the last infusion of HLX10, additional 11 subjects will be enrolled. These 17 subjects (6+11) will be evaluated for efficacy. In the second stage of trial, 27 additional subjects will be enrolled. Total 44 subjects \[stage I (n=17) + stage II (n= 27) = total (n=44)\] will be accrued in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Treatment of CHB patient with HLX10
Treatment NAs for chronic hepatitis B subject to achieve adequate HBV viral suppression
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGChina Medical University Hospital
Taichung, Taiwan
RECRUITINGNational Taiwan University Hospita
Taipei, Taiwan
RECRUITINGThe proportion of the subjects who achieve 0.5 log decline in HBsAg log10 IU/mL from baseline
Efficacy of HLX10 for treatment of chronic HBV
Time frame: 12 week
The proportion of the subjects who achieve 1 log decline in HBsAg log10 IU/mL from baseline
Efficacy of HLX10 for treatment of chronic HBV
Time frame: 24 weeks
The proportion of subjects with chronic hepatitis B that achieve HBsAg seroclearance after receiving treatment with HLX10.
HLX10 for curative treatment of chronic HBV
Time frame: 9 months
The proportion of subjects with chronic hepatitis B who suffered from hepatitis flare after receiving HLX10
Safety of HLX10 in treatment of chronic HBV
Time frame: 9 months
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